Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUniversity of Maryland, Baltimore
About this trial
Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient 60 years of age or older.
Low energy injury mechanism.
LC1 pelvis fracture (AO/OTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
Disqualifiers
Patient did not ambulate prior to injury.
Severely frail patients (Clinical Frailty Scale ≥7).
Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
Retained implants around the pelvis that precludes or limits either study treatment.
Trial population
Patients ≥ 60 years of age with a closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical stabilization of pelvic fracture
Procedure/SurgerySurgical stabilization of pelvic fracture through placement of orthopaedic hardware.
Closed treatment of pelvic fracture
Other interventionPelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Patient2 interventions
Trial outcomes
Primary outcomes
1
Patient Willingness to Enroll in a Trial
Willingness to enroll in a trial will be assessed as a binary variable with the central three choices representing that the participant is willing to have their treatment randomized.
Time frame
4 months2
Surgeon Willingness to Randomize Patient Treatment
Surgeon willingness to enroll the patient in the trial will be assessed as a binary variable with the central three choices representing that the surgeon would have been willing to have their treatment decision randomized.
Time frame
4 months3
Completeness of Patient Centered Outcomes Collected
The outcome measure completion will be assessed as a binary variable classified as either complete documentation or missing documentation.
Time frame
4 monthsSponsors and contacts
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University of Maryland, Baltimore
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov